Glivec cleared for five new disorders in USA

Swiss drug major Novartis says that its breathrough drug Glivec (imatinib) has received US regulatory approval to treat five distinct and potentially life-threatening disorders. The Food and Drug Adminsitration cleared the tyrosine kinase inhibitor for the treatment of the solid tumor cancer, dermatofibrosarcoma protuberans, relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, myelodysplastic disease, hypereosinophilic syndrome and aggressive systemic mastocytosis.

Novartis noted that this is the first time that a regulatory authority has ever simultaneously approved one targeted medicine for so many disorders, adding that all of the new indications are rare so that, for many of the patients who suffer from them, few if any approved treatments were available prior to Glivec.

In addition to the FDA-approved indications, Glivec is cleared in more than 90 countries for the treatment of all phases of Ph+ chronic myeloid leukemia. The agent is also approved for the treatment of patients with CD117-positive gastrointestinal tumors that cannot be surgically removed or have already metastasized. Novartis said that Glivec's multiple approvals in only five years validates its strategy of targeting a single pathway common to different diseases.